Study on the Effects of Sertraline on Anxiety and Depression in Heart Failure Patients with Preserved Ejection Fraction

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What is this study about?

This clinical trial is focused on studying the effects of the medication sertraline on patients who have heart failure with preserved ejection fraction and are experiencing anxiety-depressive symptoms. Heart failure with preserved ejection fraction is a condition where the heart’s ability to pump blood is not as effective as it should be, but the heart’s pumping capacity is still within normal limits. Sertraline is a medication commonly used to treat depression and anxiety. In this study, some participants will receive sertraline, while others will receive a placebo.

The purpose of the study is to understand how sertraline affects anxiety and depression symptoms, as well as certain heart-related health markers, in people with this type of heart failure. Participants will be monitored over a period of time to see if there are any changes in their symptoms or health status. The study will also look at how sertraline might impact the time it takes for participants to be hospitalized for heart-related issues or any other cause, as well as the time to any cause of death.

Throughout the study, participants will undergo regular assessments to track their mental health using tools like the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) scale. These assessments will help determine any changes in anxiety and depression levels. Additionally, the study will evaluate other health indicators, such as biomarkers related to the function of blood vessels, to gain a comprehensive understanding of sertraline’s effects on heart health and mental well-being in these patients.

1 joining the study

Upon joining the study, express willingness to participate and sign an informed consent form. This confirms understanding of the study details and agreement to participate.

2 initial assessment

An initial assessment will be conducted to ensure eligibility. This includes confirming age between 60 and 85 years, and a score of 10 or more on the Patient Health Questionnaire (PHQ-9) or the Generalized Anxiety Disorder scale (GAD-7).

A diagnosis of heart failure with preserved ejection fraction (HFpEF) will be confirmed or newly diagnosed based on specific criteria.

3 medication administration

Receive the medication Asentra, which contains sertraline. This is a film-coated tablet taken orally.

The dosage is 50 mg, and the frequency and duration of administration will be specified by the study team.

4 ongoing monitoring

Throughout the study, regular monitoring will occur to assess health status and any changes in symptoms.

This includes tracking time to hospitalization for cardiovascular reasons or death from any cause, as well as changes in scores on the PHQ-9 and GAD-7 scales.

5 completion of study

The study is estimated to end by December 31, 2026. Upon completion, final assessments will be conducted to evaluate the effects of the medication on anxiety-depressive symptoms and other health markers.

Who Can Join the Study?

Express a willingness to participate in the study and sign an informed consent form after receiving information about the study.
Be between the ages of 60 and 84 years old.
Have a score of 10 or higher on the Patient Health Questionnaire (PHQ-9), which measures depression, and/or a score of 10 or higher on the Generalized Anxiety Disorder (GAD-7) questionnaire, which measures anxiety.
Have a documented diagnosis of HFpEF (Heart Failure with preserved Ejection Fraction) or receive a new diagnosis of HFpEF based on a score of 5 or more according to the HFA-PEFF criteria during the screening phase.

Who Cannot Join the Study?

Patients with severe kidney disease cannot participate. This means if your kidneys are not working well, you may not be eligible.
Patients with severe liver disease are excluded. If your liver is not functioning properly, you may not be able to join.
If you have had a heart attack in the last 3 months, you cannot take part in the study.
Patients with uncontrolled high blood pressure are not eligible. This means if your blood pressure is not well-managed with medication, you may be excluded.
If you have a history of stroke in the last 6 months, you cannot participate.
Patients with cancer that is not in remission are excluded. Remission means the cancer is not currently active or growing.
If you are currently participating in another clinical trial, you cannot join this study.
Pregnant or breastfeeding women are not eligible to participate.
Patients with severe mental health disorders that are not stable are excluded. This means if your mental health condition is not well-controlled, you may not be able to join.
If you have a known allergy to the study medication, you cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland
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Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy	Bydgoszcz	Poland
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Kbaqjx Lapd	Gdansk	Poland
Ulvqxcjiqthryq Chmpkgw Mxxmqpid Mkzwnqqd I Thjpvlufpkx	Gdynia	Poland
Ncqihsizngrr Zwmaqt Ornkgq Zewravbbrr	Gdansk	Poland
Ufeoyidonknybo Citfvzz Kcoobfawz	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

Sertraline

Sertraline is a medication commonly used to treat depression and anxiety. In this clinical trial, it is being tested to see if it can help reduce anxiety and depressive symptoms in patients who have heart failure with preserved ejection fraction. The researchers are also interested in understanding if sertraline can improve the function of blood vessels and affect certain biological markers related to heart health. By studying these effects, the trial aims to determine if sertraline can help reduce the risk of hospitalization for heart-related issues or death from any cause in these patients.

Investigated diseases:

Depressive-anxiety states in people with heart failure with preserved ejection fraction – This condition involves the presence of both depressive and anxiety symptoms in individuals who have heart failure with preserved ejection fraction (HFpEF). In HFpEF, the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats, leading to symptoms like shortness of breath and fatigue. The depressive-anxiety states can manifest as persistent sadness, loss of interest in activities, excessive worry, and restlessness. These psychological symptoms can exacerbate the physical symptoms of heart failure, leading to a decline in overall well-being. The progression of depressive-anxiety states can vary, with symptoms potentially becoming more severe over time if not addressed. The interaction between mental health and heart failure symptoms can create a cycle that impacts the quality of life.

Trial ID:

2024-515061-33-00

Protocol code:

NBK531/1/2022

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Sertraline on Anxiety and Depression in Heart Failure Patients with Preserved Ejection Fraction

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